- 100% specificity as determined by testing 88 samples collected prior February 2019
- 100% sensitivity as determined by testing 30 samples of recovered COVID-19 patients confirmed with positive RT-PCR and symptomatic contacts of these, all of which tested positive for SARS-CoV-2 IgG antibodies using a CE IVD marked chemiluminescent assay
- standard Elisa protocol, results in less than 2 hours
- suitable for automatic platforms
- extremely low background (the OD for negative samples is 0.038 ± 0.016)
- developed by a small but enthusiastic Romanian research group with vast experience in clinical diagnostics
|Step||Reagents||Reagent quantity||Undiluted controls||1/101 diluted samples||Incubation time||Washing method|
|1||–||–||50 μl||50 μl||60 min||5×350 μl|
|2||Enzyme conjugate||50 μl||15 min||5×350 μl|
|3||TMB substrate||50 μl||20 min||–|
|4||Stop solution||25 μl||–||–|
SARS-CoV-2 is a single stranded RNA virus that caused an unprecedented global health emergency in modern times. The virus belongs to the family of coronaviruses, and causes a wide range of symptoms in humans (respiratory, gastrointestinal and even neurological).
The mortality rate of SARS-CoV-2 infection is strongly age-dependent, with more than 1,300,000 deaths and 54 million infections worldwide as of November 2020. The virus is mainly thought to spread through close human-human contacts in respiratory droplets, and new evidence points to possible longer-range transmission through air.
The majority of symptomatic individuals produce an immune response that causes the appearance of antibodies specific to virus proteins. IgM type antibodies appear 5-7 days after the onset of symptoms, while IgG antibodies can be detected after 1-2 weeks the earliest. The SARS-CoV-2 specific IgG status of a person can be determined with this Elisa test and used to establish past exposure to the virus. The immune response can be monitored over time to evaluate the likelihood of protection against reinfection.